Description
Rifabutin is used to help prevent Mycobacterium avium complex (MAC) disease from causing disease throughout the body in patients with advanced human immunodeficiency virus (HIV) infection. MAC is an infection caused by two similar bacteria, Mycobacterium avium and Mycobacterium intracellulare. Mycobacterium avium is more common in patients with HIV infection. MAC also may occur in other patients whose immune system is not working properly. Symptoms of MAC in people with acquired immunodeficiency syndrome (AIDS) include fever, night sweats, chills, weight loss, and weakness. Rifabutin is an antibiotic and works to kill or prevent the growth of certain bacteria. It will not help against viruses.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rifabutin in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifabutin in the elderly. However, elderly patients are more likely to have kidney, liver, or heart disease which may require caution and an adjustment in the dose for patients receiving rifabutin.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Artemether
- Delamanid
- Delavirdine
- Lonafarnib
- Lumefantrine
- Lurasidone
- Mavacamten
- Ranolazine
- Rilpivirine
- Voriconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Alfentanil
- Amiodarone
- Amprenavir
- Apremilast
- Atazanavir
- Atogepant
- Atovaquone
- Avacopan
- Avapritinib
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Boceprevir
- Brigatinib
- Buprenorphine
- Capivasertib
- Capmatinib
- Carbamazepine
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Codeine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabigatran Etexilate
- Daclatasvir
- Daridorexant
- Darunavir
- Desogestrel
- Dienogest
- Dihydrocodeine
- Diltiazem
- Doravirine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azithromycin
- Dapsone
- Didanosine
- Ospemifene
- Sirolimus
- Sulfamethoxazole
- Trimetrexate
- Zidovudine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea or
- Myositis (inflammation of the muscle) or
- Uveitis (an eye problem)—Use with caution. May make these conditions worse.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Tuberculosis, active—Should not be used in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.
You may take the medicine with or without food. However, if this medicine upsets your stomach, you may want to take it with food.
If you cannot swallow the capsule, you may open it and the contents of the capsules may be mixed with applesauce. Be sure to take all the food to get the full dose of medicine.
To help prevent MAC disease, it is very important that you keep using this medicine for the full time of treatment. You may have to take it every day for many months. It is important that you do not miss any doses.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For the prevention of Mycobacterium avium complex (MAC):
- Adults—300 milligrams (mg) once a day, or 150 mg two times a day with food.
- Children—Use and dose must be determined by your doctor.
- For the prevention of Mycobacterium avium complex (MAC):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check for unwanted effects.
Do not take this medicine together with delavirdine (Rescriptor®) or voriconazole (Vfend®).
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, diarrhea, fast heartbeat, joint or muscle pain, red, irritated eyes, sore throat, trouble breathing or swallowing, large, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, tightness in the chest, or unusual tiredness or weakness while you are using this medicine.
Rifabutin will cause your urine, stools, saliva, skin, sputum, sweat, and tears to turn reddish-orange to brown-orange. This is to be expected while you are taking this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. It is best not to wear soft contact lenses while taking this medicine. Hard contact lenses are not discolored by rifabutin. If you have any questions about this, check with your doctor.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Check with your doctor right away if you have black, tarry stools, blistering, peeling, loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)).
Rifabutin can lower the number of white blood cells in your blood temporarily, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. These problems may result in a greater chance of getting certain infections, slow healing, and bleeding of the gums. Be careful when using a regular toothbrush, dental floss, or toothpick. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
Birth control pills may not work properly if you take them while you are taking rifabutin. Unplanned pregnancies may occur. Use a different means of birth control while you are taking rifabutin. If you have any questions about this, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Black, tarry stools
- chest pain
- chills
- cough
- diarrhea
- fever
- heartburn
- indigestion
- itching or skin rash
- loss of appetite
- loss of strength or energy
- muscle pain
- painful or difficult urination
- sore throat
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Rare
- Bruising or purple spots on the skin
- change in taste
- eye pain
- joint pain
- loss of vision
- lower back or side pain
- muscle swelling or pain
- pale skin
- yellow skin
Incidence not known
- Burning, dry, or itching eyes
- discharge, excessive tearing
- hoarseness
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- stomach cramps, pain, or tenderness
- watery and severe diarrhea, which may also be bloody
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Bad, unusual, or unpleasant (after) taste in the mouth
- belching
- bloated or full feeling
- discoloration of the urine
- excess air or gas in the stomach or intestines
- headache
- nausea
- passing gas
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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